Registration Dossier
Registration Dossier
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EC number: 263-423-1 | CAS number: 62125-22-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP/GCP study (no data on test substance purity)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Induction: Ten repeated applications of test substance to the same site (24 h application, 24 rest period between two applications).
Challenge: A single application on the treated and at naïve site. Reading of skin alterations. - GLP compliance:
- no
Test material
- Reference substance name:
- 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)
- EC Number:
- 263-423-1
- EC Name:
- 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)
- Cas Number:
- 62125-22-8
- Molecular formula:
- not available UVCB
- IUPAC Name:
- 3-[(3-methylnonadecanoyl)oxy]-2,2-bis({[(3-methylnonadecanoyl)oxy]methyl})propyl 3-methylnonadecanoate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Lot/batch No.: PE3797/3508, 1/85
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 55 (initially 56, but 1 subject did not complete the study)
- Sex: male/female
- Age: 19 - 65 - Controls:
- no
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: 2.54 x 2.54 cm Webril pads (cotton), held in place with Dermicel tape
- Volume applied: 0.15 mL
- Testing/scoring schedule:
The test substance was applied to backs of volunteers for 24h using patches followed by a 24-h (when applied on Monday and Wednesday) or a 48-h rest period (when applied on Friday). The procedure was repeated for a total of 10 applications. After the last application, a 14-day rest period followed. A single application to the original and at naïve site was used for challenge. Scoring was done 24 and 48 h after patch removal.
- Removal of test substance: no
EXAMINATIONS
- Grading/Scoring system:
0 = no visible reaction
1+ = mild erythema
2+ = well-defined erythema
3+ = erythema and edema
4+ = erythema and edema with vesiculation and ulceration
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: none
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: none
- Number of subjects with negative reactions: 55
- Number of subjects with equivocal reactions: none
- Number of subjects with irritating reactions: none
Applicant's summary and conclusion
- Conclusions:
- not sensitising
CLP: not classified
DSD: not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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